ENHANCE Study
Research type
Research Study
Full title
Liquid Biopsy for Early DiagNosis of Squamous cell Carcinoma of the HeAd and NeCk rEgion (ENHANCE Study)
IRAS ID
292104
Contact name
Ann Gandolfi
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The 5-year survival for Head and Neck squamous cell carcinoma (HNSCC) across all TNM stage groups is approximately 50% [1]. Patients who present with stage I &II disease have significantly better survival. When a patient presents to their general practitioner (GP) with symptoms suggestive of HNSCC, they may be referred for urgent specialist input through the suspected cancer referral (SCR) pathway, which include dedicated neck lump clinics. Majority of the patients diagnosed via the SCR pathway present with Stage III &IV disease, which has a direct impact on outcomes.
Furthermore, HNSCC is classified as an uncommon cancer and as such diagnosis and treatment is undertaken in specialist tertiary referral centres. The care of patients initially diagnosed with HNSCC in smaller secondary care hospitals is transferred to these specialist tertiary referral centres via the Inter Trust Transfer (ITT). ITT can introduce delays in treatment pathways resulting in failure of achieve cancer treatment targets. Southwest London HNSCC diagnostic pathway review undertaken in February 2021, demonstrated that 40% of ITTs were received greater than 38 days after referral and that 68% of the 62 day target breaches were in patients with ITT.
HNSCC is known to shed fragments of DNA, called circulating tumor DNA (ctDNA) into the bloodstream [2]. We have developed novel ultra-sensitive (>90% sensitivity) next generation sequencing (NGS) assay for circulating HPV DNA [3] in patients with non-metastatic locally advanced head and neck cancer. Our current work involves ctDNA detection to cover the spectrum of genetic alterations in HNC using a single sequencing workflow to detect copy number aberrations (CNAs), HPV DNA (to cover 99.9% of HNC related HPV) and somatic mutations.
Use of ultra-sensitive NGS assay for detection of ctDNA using a simple blood test (liquid biopsy) holds great promise for cancer screening and early diagnosis and can lead to better survival results and less disease burden. This has been proven in proof of principle studies in nasopharyngeal cancer [4] (Chan N Engl J Med 2017; 377:513-522). Furthermore, this test can be administered in smaller secondary care hospitals in parallel to the ITT. With a quicker turnaround (1-2 weeks), the liquid biopsy can help expedite the patient journey through the cancer pathways reducing the incidence of cancer target breaches. In order to design studies to test this hypothesis we require preliminary data quantifying sensitivity and specificity of our assay in this setting.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
22/EM/0151
Date of REC Opinion
8 Jul 2022
REC opinion
Favourable Opinion